Last updated: 11/03/2018 10:56:45

Immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in people 18 years old or above

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GSK study ID
110221
See study documents
Clinicaltrials.gov ID
NCT00476307
EudraCT ID
2007-001828-12
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in people aged 18 years or above
Trial description: This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix™/Influsplit SSW® 2007/2008
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
June 2007 to July 2007
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • Healthy male or female aged 18 years or above;
  • Non-childbearing or using adequate contraception;
  • Subjects must not:
  • Participate in a trial or using non-registered product;
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy male or female aged 18 years or above;
  • Non-childbearing or using adequate contraception;
  • Written informed consent obtained from the subject.
Exclusion criteria:
  • Subjects must not:
  • Participate in a trial or using non-registered product;
  • Use immunosuppressants, blood products, or another influenza vaccine during study;
  • Have virologically confirmed influenza within 1 year;
  • Have allergic or acute disease;
  • Have unstabilized serious chronic disease;
  • Be a lactating female.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
Status
Study Complete
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Location
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Status
Study Complete
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Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-11-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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